Discover and read the best of Twitter Threads about #Murcidencel
Most recents (4)
This draft guidance is wonderful in that FDA reminds us that there has been a long-standing precedent (decades) for use of external controls as "substantial evidence of effectiveness" and approval.
But is it relevant?...
fda.gov/media/164960/d…
$NWBO #Murcidencel Glioblastoma
But is it relevant?...
fda.gov/media/164960/d…
$NWBO #Murcidencel Glioblastoma
This draft guidance is focused on "patient-level data" which might not relate to #Murcidencel - In that case, FDA would be able to cite the decades old precedent.
Recall that Avastin and Optune were both FDA approved but didn't improve survival in rGBM, unmet need.
$NWBO
Recall that Avastin and Optune were both FDA approved but didn't improve survival in rGBM, unmet need.
$NWBO
In summary, this draft guidance is overall positive for $NWBO as it
1 shows FDA flexibility and precedent for use of external controls as substantial evidence of effectiveness
2 aims to formalize a portion of the precedent into official "guidance" for industry
$XBI Cancer Vaccine
1 shows FDA flexibility and precedent for use of external controls as substantial evidence of effectiveness
2 aims to formalize a portion of the precedent into official "guidance" for industry
$XBI Cancer Vaccine
CIs didn’t work, so synergy is *non-obvious*
Further, IF ANYTHING, field was maybe suggesting that neoadjuvant was only place it might work. BUT *unexpectedly* adjuvant works best.
Patentability = war, highly competitive, highly lucrative CI market
$NWBO $MRK #PD1 #Checkpoint
Further, IF ANYTHING, field was maybe suggesting that neoadjuvant was only place it might work. BUT *unexpectedly* adjuvant works best.
Patentability = war, highly competitive, highly lucrative CI market
$NWBO $MRK #PD1 #Checkpoint
The combo data reduced this non-obvious, unexpected phenomenon to practice, in my opinion.
1 + 0 = 6
$NWBO $MRK
1 + 0 = 6
$NWBO $MRK
Exploring Adjuvants with #DCVaxL: POLY ICLC TLR 3 Agonist adjuvant discussion, #DrLindaLiau, early trial P 1. Using adjuvants w/ #DCVaxL $NWBO #Murcidencel #DCVax
Survival Data w/Adjuvants, small early trial:
Survival Data w/Adjuvants, small early trial:
Fuller Discussion re early trial with #DCVaxL + adjuvants, including Poly ICLC:
Re single agent checkpoint inhibitors, without DCVaxL, in Glioblastoma:
$NWBO #DCVaxL New name #murcidencel
SNO Abstract, just released, for presentation by #DrLindaLiau on November 20th:
Background: Standard of care (SOC) and patient survival in glioblastoma have changed little in the past 17 years.
SNO Abstract, just released, for presentation by #DrLindaLiau on November 20th:
Background: Standard of care (SOC) and patient survival in glioblastoma have changed little in the past 17 years.
We evaluated in a phase 3 trial whether adding an autologous tumor lysate-loaded dendritic cell vaccine (murcidencel) to SOC extends survival. Patients and
Methods: Newly diagnosed glioblastoma patients were randomized 2:1 to either murcidencel or placebo.
Methods: Newly diagnosed glioblastoma patients were randomized 2:1 to either murcidencel or placebo.
Under a crossover design, all patients could receive murcidencel following tumor recurrence. All parties remained blinded regarding treatments before recurrence. Patients thus received murcidencel at new diagnosis (nGBM) or at recurrence (rGBM) following crossover from placebo.
